Critical care medicine · 2026
Reducing Physical Restraint in the ICU: Multicenter Phase II Randomized Trial of a Novel Device Versus Traditional Wrist Restraints.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Stapleton Renee D, Kamdar Biren B, Colantuoni Elizabeth A, Pandian Vinciya, Friedman Lisa Aronson, Bates Jason H T, Ardren Sara S, Burns Stephanie, Fatima Arooj, Fine Janelle M, Kalva Teja, Mahmoud Mazin Ali, Roberts Darin, Ventrone Sebastian, Viana Julia, McGinnis Ryan S, Pavini Marie T, Needham Dale M, FREEDOM Study Team
Аннотация
OBJECTIVES: To evaluate a novel device, developed under a National Institutes of Health Small Business Technology Transfer program grant, designed as an alternative to traditional wrist restraints.
DESIGN: Within-patient crossover phase II randomized trial.
SETTING: Four U.S. academic medical centers.
PATIENTS: ICU patients ( n = 54) who were verbally responsive with a provider order for wrist restraints and expected stay greater than or equal to 2 days.
INTERVENTIONS: Alternating use of novel device vs. traditional restraint during 4-hour assessment periods over 2 days (four assessment periods), with randomization of initial allocation to novel device vs. restraint.
MEASUREMENTS AND MAIN RESULTS: Upper extremity activity (measured via wrist actigraphy) was the primary outcome, with safety, sedation, delirium, satisfaction (via Quebec User Evaluation of Satisfaction with Assistive Technology [QUEST] survey), and qualitative analyses of survey data as secondary outcomes. Analysis of actigraphy data demonstrated similar mean activity counts per 4-hour session for the novel device vs. traditional restraints, with a range of mean activity across the four sessions of 2930-4395 vs. 3898-4910, respectively, with relative mean total activity count per session of 0.93 (95% CI, 0.76-1.13; p = 0.45). Across 98 sessions using the novel device, 2 (2%) potential safety events were reported. No statistically significant differences were observed in sedation/agitation, or delirium status and severity. Of the QUEST satisfaction surveys completed by patient/family ( n = 25) and clinicians ( n = 79), 58% and 51%, respectively, indicated high satisfaction with qualitative analyses demonstrating four positive and six constructive themes.
CONCLUSIONS: No differences in upper extremity activity, delirium, sedation, or agitation were demonstrated between the novel device and traditional wrist restraints. The novel device had overall moderate patient/family and clinician satisfaction, and qualitative analyses provide important insights for advancing the development of novel restraint alternative devices.
DESIGN: Within-patient crossover phase II randomized trial.
SETTING: Four U.S. academic medical centers.
PATIENTS: ICU patients ( n = 54) who were verbally responsive with a provider order for wrist restraints and expected stay greater than or equal to 2 days.
INTERVENTIONS: Alternating use of novel device vs. traditional restraint during 4-hour assessment periods over 2 days (four assessment periods), with randomization of initial allocation to novel device vs. restraint.
MEASUREMENTS AND MAIN RESULTS: Upper extremity activity (measured via wrist actigraphy) was the primary outcome, with safety, sedation, delirium, satisfaction (via Quebec User Evaluation of Satisfaction with Assistive Technology [QUEST] survey), and qualitative analyses of survey data as secondary outcomes. Analysis of actigraphy data demonstrated similar mean activity counts per 4-hour session for the novel device vs. traditional restraints, with a range of mean activity across the four sessions of 2930-4395 vs. 3898-4910, respectively, with relative mean total activity count per session of 0.93 (95% CI, 0.76-1.13; p = 0.45). Across 98 sessions using the novel device, 2 (2%) potential safety events were reported. No statistically significant differences were observed in sedation/agitation, or delirium status and severity. Of the QUEST satisfaction surveys completed by patient/family ( n = 25) and clinicians ( n = 79), 58% and 51%, respectively, indicated high satisfaction with qualitative analyses demonstrating four positive and six constructive themes.
CONCLUSIONS: No differences in upper extremity activity, delirium, sedation, or agitation were demonstrated between the novel device and traditional wrist restraints. The novel device had overall moderate patient/family and clinician satisfaction, and qualitative analyses provide important insights for advancing the development of novel restraint alternative devices.